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Table of Contents
                            Contents
Preface
Acknowledgments
Chapter 1: Scope
Chapter 2: Normative References
Chapter 3: Terms and Definitions
Chapter 4: Quality Management System
Chapter 5: Management Responsibility
Chapter 6: Resource Management
Chapter 7: Product Realization
Chapter 8: Measurement, Analysis, and Improvement
Back Cover
                        
Document Text Contents
Page 1

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Composite

C M Y CM MY CY CMY K

K12946

w w w. c rc p r e s s . c o m

an informa business

6000 Broken Sound Parkway, NW
Suite 300, Boca Raton, FL 33487
711 Third Avenue
New York, NY 10017
2 Park Square, Milton Park
Abingdon, Oxon OX14 4RN, UK w w w . c r c p r e s s . c o m

Abuhav

ISO 13485
A Complete Guide to Quality Management
in the Medical Device Industry

IS
O

13
4

8
5

Although complex and lengthy, the process of certification for the ISO 13485 can
be easily mastered using the simple method outlined in ISO 13485: A Complete
Guide to Quality Management in the Medical Device Industry. Written by an
experienced industry professional, this practical book provides a complete guide
to the ISO 13485 Standard certification for medical device manufacturing.

Filled with examples drawn from the author’s experience and spanning different
sectors and fields of the medical device industry, the book translates the
extraordinary requirements and objectives of the standard into feasible activities
and tasks. Presenting from-the-trenches advice from a quality manager to quality
managers and other organizational parties in the field, this book:

• Clarifies and interprets the ISO 13485 Standard requirements in detail

• Refers to the harmonization of regulatory requirements with the quality
management system and the integration of risk management activities
throughout the realization processes (with reference to the ISO 14791 standard)

• Provides a large number of examples of how one can implement the
requirements drawn from various sectors and industries

• Puts words into actions, translating the requirements and objectives into feasible
activities and tasks

• Includes a full and comprehensive reference to the interrelations between the
different clauses and sub clauses of the standard

The book is organized like the standard itself — the table of contents is identical
to the ISO 13485 Standard’s table of contents — making it user friendly, familiar,
and unintimidating. You can use the book as a consulting session — read it,
explore it ,extract ideas — and draw on the information and knowledge that
suits you and your organization, and then apply it effectively to your quality
management system and processes.

BIOMEDICAL ENGINEERING

Page 2

ISO 13485
A Complete Guide to
Quality Management
in the
Medical Device
Industry

Page 183

168 ISO 13485: Quality Management in the Medical Device Industry

List of Approved Suppliers

Next,. you. are. required. to. add. any. accepted. supplier. into. a. documented. list. of.
approved. suppliers—also. referred. to. as. ASL. (approved. suppliers. list).. The. sup-
plier’s.rank.(relating.to.the.criteria).can.be.put.on.the.list,.but.it. is.not.obligatory..
There.is.no.specific.requirement.for.a.list.on.the.ISO.13485.Standard..It.is,.however,.
a. logical. output. of. the. evaluation. process. thus. required.. The. requirement. is. that.
any.actions.arising.from.the.evaluation.should.be.maintained;.that.is,.documented..
After.evaluation.you.are.left.with.a.list.of.approved.suppliers..You.shall.be.required.
to.show.this.during.the.audit..This.list.is.one.of.the.quality.records.of.the.purchase.
process.and.needs.to.be.controlled.

Advice:. If.you.maintain. an.ERP.system.or.any.other. system. that.manages.your.
purchasing.processes,. (naturally).your. suppliers.will.be.documented.on. the. system..
You.need.only.define,.on.the.procedure,.that.approved.suppliers.are.documented.on.
your.ERP.system..Using.the.status.of.your.supplier.on.that.system.(e.g.,.whether.they.
are.active,.inactive,.suspended,.etc.),.you.may.declare.and.document.the.approval. You.
may.also.produce.a.report.from.the.system:.a.list.of.approved.suppliers..This.option.
may.allow.you.to.keep.the.list.up.to.date.

Records

The. standard. clearly. requires. maintaining. records. (i.e.,. outputs. of. the. processes).
related.to.the.purchasing.processes.under.your.records.control.method..The.target.of.
the.records.is.to.provide.objective.evidence.that.the.processes.were.conducted,.and,.
more.importantly,.that.they.are.effective..Let.us.review.the.expected.records:

•. Details.of.suppliers:.names,.addresses,.and.contact.persons
•. Product. specifications:. agreements. or. contracts. with. the. suppliers,. purchase.

orders,.and.so.on
•. Regulatory.requirements
•. Inputs.from.the.supplier;.MSDS,.REACH.certifications,.quality.certifications,.

and.internal.certifications.of.suppliers
•. Inspection.of.parts.and.products:.quality.tests,.quality.protocols,.and.samplings
•. List.of.risks.related.to.a.supplier
•. List.of.controls.related.to.a.supplier:.work.and.test.instructions,.process.diagrams
•. Criteria.for.evaluation
•. Records.related.to.the.purchase.order
•. Correspondence.with.suppliers:.e-mails,.meeting.summaries
•. Records.of.suppliers’.evaluations
•. List.of.approved.suppliers

Not.all.of. the.above.need.be. included..Naturally,. the.outputs.and. inputs.of.your.
purchase.processes.(the.records).are.to.be.specified.on.your.quality.records.list,.and.
submitted.to.a.control.of.records.as.specified.in.subclause.4.2.4.(Control.of.Records).

7.4.2 PURCHASING INFORMATION

Purchasing. information. shall. indicate. your. product’s. specifications. and. require-
ments.for.you.and.for.your.suppliers..The.ability.to.transfer.to.your.supplier.clear.
specifications. regarding. the. product. is. essential.. In. certain. cases. the. information.
will.be.the.comparison.criteria.between.what.you.have.ordered.and.what.you.have.

Page 184

Product Realization 169

received. The organization shall ensure that an order (or a transfer) of information
contains the required details prior to delivery to the supplier. While de�ning the
information of the purchase products, the organization would refer to the following
issues (Table 7.17).

When de�ning the information for the purchase, the organization shall:

• Determine and document the designated supplier and add references to
relevant agreements or contracts.

• De�ne and document all information that identi�es the required product
for purchase—name or description of the product or service, catalog num-
ber (internal or external), edition, edition of diagram, con�guration, and
model.

• De�ne information regarding the purchase process—required quantities,
delivery dates, prices, discounts, and addresses for delivery and billing.

• De�ne operational requirements, technical speci�cations, instructions, and
guidance that the supplier must follow—packaging requirements, delivery
requirements, transportation conditions, development environment, opera-
tion environment, work instructions, procedures, and diagrams.

• De�ne quality requirements—test instructions, inspection instruction,
quality records, quality protocols, tools and equipment for control, quality
certi�cations, and statistical data.

• Identify necessary training regarding the purchased product.

TABLE 7.17
Standard Requirements of Subclause 7.4.2

ISO 13485 ISO 9001

The information of a purchased product will
de�ne the product and its characteristics; that is,
the speci�cations and requirements

The information of a purchased product will
de�ne the product and its characteristics; that is,
the speci�cations and requirements

The organization shall de�ne requirements for the
control and approval of a purchased product

The organization shall de�ne requirements for the
control and approval of a purchased product

The de�nition shall refer to the determination of
processes, procedures, and the use of tools,
equipment, and procedures

The information shall refer to the determination of
processes, procedures, and the use of tools,
equipment, and procedures

The information shall include training and
quali�cation requirements relevant to the
purchased product

The information shall include training and
quali�cation requirements relevant to the
purchased product

The information shall regard any quality
requirements

The information shall refer to quality management
system requirements

Traceability requirements, as presented on chapter
7.5.3.2, are also applicable to purchasing
information

The application of the traceability shall be carried
out with documents and records control as
required in chapters 4.2.4 and 4.2.3

Page 365

350 ISO 13485: Quality Management in the Medical Device Industry

The Preventive Action Records

Records and evidence of the preventive action process will be submitted to the records
control process as required in subclause 4.2.4. The main goals of the records are super-
vision and control. The expected records are:

• The potential nonconformity or reference to appropriate records.
• The root cause investigation—the records of the investigation depend on the type

of method you are using for identifying the root cause of the nonconformity.
• Evaluation—the review and evaluation for the need of preventive action will

include details such as the performer of the evaluation, the date, the consider-
ations, and conclusions or reference to relevant documentation.

• The preventive action—if a preventive action is taken it shall be speci�ed and
documented.

• Review and effectiveness—the review and evaluation of the preventive action
will include data and evidence that the nonconformity did not occur.

• The closing of the preventive action.

As mentioned already in chapter 8.5.2, there are a lot of different solutions for
documenting and controlling preventive actions—from the simple traditional forms to
sophisticated designated software. As a manufacturer you need to �nd the appropri-
ate solution for your organization and the nature of your processes. When doing so,
consider the following issues:

• Who is supposed to detect and document a potential nonconformity?
• What are the types of data to be recorded?
• Who are the addressed parties of the process?
• Who is required to update and review the process?
• Who is required to approve the results?

Page 366

K12946_cover3 9/8/11 11:07 AM Page 1

Composite

C M Y CM MY CY CMY K

K12946

w w w. c rc p r e s s . c o m

an informa business

6000 Broken Sound Parkway, NW
Suite 300, Boca Raton, FL 33487
711 Third Avenue
New York, NY 10017
2 Park Square, Milton Park
Abingdon, Oxon OX14 4RN, UK w w w . c r c p r e s s . c o m

Abuhav

ISO 13485
A Complete Guide to Quality Management
in the Medical Device Industry

IS
O

13
4

8
5

Although complex and lengthy, the process of certification for the ISO 13485 can
be easily mastered using the simple method outlined in ISO 13485: A Complete
Guide to Quality Management in the Medical Device Industry. Written by an
experienced industry professional, this practical book provides a complete guide
to the ISO 13485 Standard certification for medical device manufacturing.

Filled with examples drawn from the author’s experience and spanning different
sectors and fields of the medical device industry, the book translates the
extraordinary requirements and objectives of the standard into feasible activities
and tasks. Presenting from-the-trenches advice from a quality manager to quality
managers and other organizational parties in the field, this book:

• Clarifies and interprets the ISO 13485 Standard requirements in detail

• Refers to the harmonization of regulatory requirements with the quality
management system and the integration of risk management activities
throughout the realization processes (with reference to the ISO 14791 standard)

• Provides a large number of examples of how one can implement the
requirements drawn from various sectors and industries

• Puts words into actions, translating the requirements and objectives into feasible
activities and tasks

• Includes a full and comprehensive reference to the interrelations between the
different clauses and sub clauses of the standard

The book is organized like the standard itself — the table of contents is identical
to the ISO 13485 Standard’s table of contents — making it user friendly, familiar,
and unintimidating. You can use the book as a consulting session — read it,
explore it ,extract ideas — and draw on the information and knowledge that
suits you and your organization, and then apply it effectively to your quality
management system and processes.

BIOMEDICAL ENGINEERING

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